Pharmacokinetics and Safety of AmBisome and DKF-5122

Sponsor
Dongkook Pharmaceutical Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT05749380
Collaborator
(none)
38
1
4
16.7
2.3

Study Details

Study Description

Brief Summary

The purpose of the study is to assess the Safety and Pharmacokinetic Characteristics of AmBisome and DKF-5122

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Bioequivalence Study to Evaluate Pharmacokinetics and Safety of AmBisome and DKF-5122 in Indicated Patients and Healthy Adults
Actual Study Start Date :
Sep 7, 2020
Actual Primary Completion Date :
Jan 28, 2022
Actual Study Completion Date :
Jan 28, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: 1A(RT)

Patients (AmBisome, DKF-5122)

Drug: AmBisome
Reference, dose of 3 mg/kg.

Drug: DKF-5122
Test, dose of 3 mg/kg

Other: 1B(TR)

Patients (DKF-5122, AmBisome)

Drug: AmBisome
Reference, dose of 3 mg/kg.

Drug: DKF-5122
Test, dose of 3 mg/kg

Other: 2A(RT)

Healthy subjects (AmBisome, DKF-5122)

Drug: AmBisome
Reference, dose of 3 mg/kg.

Drug: DKF-5122
Test, dose of 3 mg/kg

Other: 2B(TR)

Healthy subjects (DKF-5122, AmBisome)

Drug: AmBisome
Reference, dose of 3 mg/kg.

Drug: DKF-5122
Test, dose of 3 mg/kg

Outcome Measures

Primary Outcome Measures

  1. Cmax [0 to 93 hr]

    Liposome encapsulated amphotericin B of healthy adult

  2. AUClast [0 to 93 hr]

    Liposome encapsulated amphotericin B of healthy adult

Secondary Outcome Measures

  1. Cmax [0 to 93 hr]

    Unbound Amphotericin B of healthy adult

  2. AUClast [0 to 93 hr]

    Unbound Amphotericin B of healthy adult

  3. AUCinf [0 to 93 hr]

    Liposome encapsulated amphotericin B and Unbound Amphotericin B of healthy adult

  4. tmax [0 to 93 hr]

    Liposome encapsulated amphotericin B and Unbound Amphotericin B of healthy adult

  5. t1/2 [0 to 93 hr]

    Liposome encapsulated amphotericin B and Unbound Amphotericin B of healthy adult

  6. CL/F [0 to 93 hr]

    Liposome encapsulated amphotericin B and Unbound Amphotericin B of healthy adult

  7. V/F [0 to 93 hr]

    Liposome encapsulated amphotericin B and Unbound Amphotericin B of healthy adult

  8. Cmin,ss [0 to 93 hr]

    Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient

  9. Cav,ss [0 to 93 hr]

    Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient

  10. tmax,ss [0 to 93 hr]

    Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient

  11. t1/2 [0 to 93 hr]

    Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient

  12. PTF (peak to trough fluctuation ratio) [0 to 93 hr]

    Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient

  13. CLss/F [0 to 93 hr]

    Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient

  14. Vd,ss/F [0 to 93 hr]

    Liposome encapsulated amphotericin B and Unbound Amphotericin B of indication patient

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Part 1. Patients
  1. Age 19 years and older

  2. Empirical therapy for presumed fungal infection in febrile, neutropenic patients

  3. Voluntarily decided to participate in the study and signed the informed consent form

  4. Having contraception during the study

  • Part 2. Healthy subjects
  1. Age 19 to 45 years

  2. Body weight 55 kg or more, within ±20% of the ideal body weight

  3. Having no congenital or chronic disease within the last 5 years.

  4. Voluntarily decided to participate in the study and signed the informed consent form

  5. Having contraception during the study

Exclusion Criteria:
  • Part 1. Patients
  1. Clinically significant conditions that may affect the pharmacokinetics of amphotericin

  2. History of diseases that may affect the pharmacokinetics of amphotericin

  3. History of drug abuse

  4. History of hypersensitivity to ingredients of investigational products

  5. Unable to maintain proper contraception

  6. Pregnant or breast-feeding

  7. The following laboratory test results at screening

  • Hemoglobin < 8.0 g/dL

  • Serum Creatinine > 2x the UNL

  • AST or ALT > 10x UNL

  • Systolic blood pressure ≥ 140 mmHg or ≤ 90 mmHg

  • Diastolic blood pressure ≥ 90 mmHg or ≤ 60 mmHg

  1. Before the first administration of investigational products
  • Participation to other clinical trials within 6 months

  • Whole blood donation within 60 days or component within 30 days

  • (Herbal) medicines that may affect the pharmacokinetics of amphotericin within 14 days

  • Grapefruit-containing foods within 7 days

  • Excessive exercise within 7 days

  1. Excessive caffeine and alcohol consumption, or a smoker

  2. Not eligible due to other reasons at the investigator's discretion

  • Part 2. Healthy subjects
  1. Clinically significant disorders or a medical history of active cardiovascular, respiratory , kidney, endocrine, hematological, digestive, central nervous system, psychiatric disease, or malignant tumor

  2. Clinically significant conditions that may affect the pharmacokinetics of amphotericin

  3. History of diseases that may affect the pharmacokinetics of amphotericin

  4. History of drug abuse

  5. History of hypersensitivity to ingredients of investigational products

  6. Unable to maintain proper contraception

  7. Pregnant or breast-feeding

  8. The following laboratory test results at screening

  • Hemoglobin < 13.0 g/dL

  • Serum Creatinine > 1.25 x UNL

  • eGFR < 90 mL/min/1.73 m2

  • AST or ALT > 1.25 x UNL

  • Total bilirubin > 1.25 x UNL

  • CPK > 1.5 x UNL

  • Systolic blood pressure ≥140 mmHg or ≤90 mmHg

  • Diastolic blood pressure ≥ 90 mmHg or ≤60 mmHg

  • Arrhythmia

  1. Before the first administration of investigational products
  • Participation to other clinical trials within 6 months

  • Whole blood donation within 60 days or component within 30 days

  • Drugs that induce or inhibit drug metabolism enzymes within 30 days

  • Vaccination within 7 days

  • Prescription drugs, herbal medicines, over-the-counters, or vitamins within 14 days

  • Grapefruit-containing foods within 7 days

  • Excessive exercise within 7 days

  1. Excessive caffeine and alcohol consumption, or a smoker

  2. Not eligible due to other reasons at the investigator's discretion

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Catholic University of Korea Seoul St. Mary's Hospital Seoul Seocho-gu Korea, Republic of 06591

Sponsors and Collaborators

  • Dongkook Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dongkook Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05749380
Other Study ID Numbers:
  • DKF-5122-BE
First Posted:
Mar 1, 2023
Last Update Posted:
Mar 1, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 1, 2023